Children and Tobacco; Executive Summary: Annex: Nicotine in Cigarettes

U.S. Food and Drug Administration

Annex: Nicotine in Cigarettes And Smokeless Tobacco Is a Drug And These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act

Jurisdictional Determination

 

FDA regulates foods, drugs, medical devices, and cosmetics.
This document explains the basis for the Food and Drug Administration's assertion of jurisdiction over cigarettes and smokeless tobacco under the Federal Food, Drug, and Cosmetic Act (the Act). FDA regulates a diverse range of products under the Act, including foods, drugs, medical devices, and cosmetics.

 

The distinguishing feature that characterizes these products is their intimate and potentially harmful relationship with the human body. The products that FDA regulates include those that are ingested, inhaled, implanted, or otherwise used in close contact with the human body.

Cigarettes, which deliver a pharmacologically active dose of nicotine to the body through inhalation, and smokeless tobacco, which delivers a pharmacologically active dose of nicotine to the body through buccal absorption, share this distinguishing feature. Like the products that FDA traditionally regulates, cigarettes and smokeless tobacco are inhaled or placed within the human body; like many of these products, they deliver a pharmacologically active substance to the bloodstream; and like these products, they have potentially dangerous effects. Indeed, no products cause more death and disease than cigarettes and smokeless tobacco.

FDA is asserting jurisdiction over cigarettes and smokeless tobacco under the drug and device provisions of the Act. Specifically, FDA has concluded that cigarettes and smokeless tobacco are combination products consisting of nicotine, a drug that causes addiction and other significant pharmacological effects on the human body, and device components that deliver nicotine to the body. FDA last considered whether cigarettes were drugs or devices in the late 1970's. See Action on Smoking and Health v. Harris, 655 F.2d 236 (D.C. Cir. 1980). Since that time, substantial new evidence has become available to FDA. This evidence includes the emergence of a scientific consensus that cigarettes and smokeless tobacco cause addiction to nicotine and the disclosure of thousands of pages of internal tobacco company documents detailing that these products are intended by the manufacturers to affect the structure and function of the human body. This new evidence justifies the Agency's determination that cigarettes and smokeless tobacco are delivery systems for the drug nicotine.

Under the Act, a product is a drug or device if it is an article (other than food) "intended to affect the structure or any function of the body." Sections 201(g)(1)(C), 201(h)(3). The statutory definition is "intended to define 'drug' far more broadly than does the medical profession." United States v. An Article of Drug . . . Bacto-Unidisk, 394 U.S. 784, 793, 798 (1969). The legal question of whether cigarettes and smokeless tobacco are subject to FDA jurisdiction is one that "FDA has jurisdiction to decide with administrative finality." Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653 (1973).

After intensive investigation and careful consideration of the public comments, FDA concludes that cigarettes and smokeless tobacco meet the statutory definition of a drug and a device. This conclusion is based on two determinations: (1) nicotine in cigarettes and smokeless tobacco does "affect the structure or any function of the body," and (2) these effects on the structure and function of the body are "intended" by the manufacturers.

The Agency's determination that nicotine in cigarettes and smokeless tobacco does "affect the structure or any function of the body" is based on three central findings:

  1. Nicotine in cigarettes and smokeless tobacco causes and sustains addiction.
  2. Nicotine in cigarettes and smokeless tobacco causes other psychoactive (mood-altering) effects, including tranquilization and stimulation.
  3. Nicotine in cigarettes and smokeless tobacco controls weight.

The Agency's determination that the manufacturers of cigarettes and smokeless tobacco "intend" these effects is based on five central findings:

  1. The addictive and other pharmacological effects of nicotine are so widely known and accepted that it is foreseeable to a reasonable manufacturer that cigarettes and smokeless tobacco will cause addiction to nicotine and other significant pharmacological effects and will be used by consumers for pharmacological purposes, including sustaining their addiction to nicotine.
  2. Consumers use cigarettes and smokeless tobacco predominantly for pharmacological purposes, including sustaining their addiction to nicotine, mood alteration, and weight loss.
  3. Manufacturers of cigarettes and smokeless tobacco know that nicotine in their products causes pharmacological effects in consumers, including addiction to nicotine and mood alteration, and that consumers use their products primarily to obtain the pharmacological effects of nicotine.
  4. Manufacturers of cigarettes and smokeless tobacco design their products to provide consumers with a pharmacologically active dose of nicotine.
  5. An inevitable consequence of the design of cigarettes and smokeless tobacco to provide consumers with a pharmacologically active dose of nicotine is to keep consumers using cigarettes and smokeless tobacco by sustaining their addiction to nicotine.

This document is divided into six sections. Section I describes the evidence and legal basis supporting the Agency's finding that cigarettes and smokeless tobacco "affect the structure or any function of the body." Section II describes the evidence and legal basis supporting the Agency's finding that the manufacturers "intend" these effects on the structure and function of the body. Section III explains the Agency's conclusion that cigarettes and smokeless tobacco are combination products that contain a "drug" and a "device." Section IV explains why the Agency's decision to assert jurisdiction over cigarettes and smokeless tobacco is justified by the new evidence now available to the Agency. Section V demonstrates that Congress has not precluded or preempted the Agency's assertion of jurisdiction over cigarettes and smokeless tobacco. Section VI addresses procedural issues relating to the Agency's assertion of jurisdiction over cigarettes and smokeless tobacco. These sections are summarized below.

I. Cigarettes and Smokeless Tobacco "Affect the Structure or any Function of the Body" Within the Meaning of the Act

The nicotine delivered by cigarettes and smokeless tobacco has significant pharmacological effects on the structure and function of the body.

First, the nicotine in cigarettes and smokeless tobacco causes and sustains addiction. Nicotine exerts psychoactive, or mood-altering, effects on the brain that motivate repeated, compulsive use of the substance. These pharmacological effects create dependence in the user. The pharmacological processes that cause this addiction to nicotine are similar to those that cause addiction to heroin and cocaine.

Second, the nicotine in cigarettes and smokeless tobacco produces other important pharmacological effects on the central nervous system. Under some circumstances and doses, the nicotine has a sedating or tranquilizing effect on mood and brain activity. Under other circumstances and doses, the nicotine has a stimulant or arousal-inducing effect on mood and brain activity.

Third, the nicotine in cigarettes and smokeless tobacco affects body weight.

These effects on the structure and function of the body are significant and quintessentially drug-like. Moreover, these effects are the same as the effects of other drugs that FDA has traditionally regulated, including stimulants, tranquilizers, appetite suppressants, and products, such as methadone, used in the maintenance of addiction. For these reasons, the Agency finds that cigarettes and smokeless tobacco "affect the structure or any function of the body" within the meaning of the Act.

II. Cigarettes and Smokeless Tobacco Are "Intended" to Affect the Structure and Function of the Body Within the Meaning of the Act

To determine whether effects on the structure or function of the body are "intended" by the manufacturer, the Agency must objectively evaluate all the relevant evidence of intent in the record before it. "The FDA is not bound by the manufacturer's subjective claims of intent," but rather can find actual intent "on the basis of objective evidence." National Nutritional Foods Ass'n v. Matthews, 557 F.2d 325, 334 (2d Cir. 1977). In the case of cigarettes and smokeless tobacco, the Agency finds that three types of objective evidence provide independent bases for finding that the manufacturers intend to affect the structure and function of the body: (1) the evidence of the foreseeable pharmacological effects and uses of cigarettes and smokeless tobacco; (2) the evidence of the actual consumer use of cigarettes and smokeless tobacco for pharmacological purposes; and (3) the evidence of the statements, research, and actions of the manufacturers themselves. Considered independently or cumulatively, this evidence convincingly demonstrates that cigarettes and smokeless tobacco are intended to be used for pharmacological purposes.

A. A Reasonable Manufacturer Would Foresee that Tobacco Products Will Cause Addiction and Other Pharmacological Effects and Will Be Used by Consumers for Pharmacological Purposes

When Congress enacted the current definition of "drug" in 1938, it was well understood that "[t]he law presumes that every man intends the legitimate consequences of his own acts." Agnew v. United States, 165 U.S. 36, 53 (1897). Consistent with this common understanding, FDA's regulations provide that a product's intended pharmacological use may be established by evidence that the manufacturer "knows, or has knowledge of facts that would give him notice," that the product is being widely used for a pharmacological purpose, even if the product is not being promoted for this purpose. 21 CFR 201.128, 801.4. Thus, FDA may find that a manufacturer intends its product to affect the structure or function of the body when it would be foreseeable to a reasonable manufacturer that the product will (1) affect the structure or function of the body and (2) be used by a substantial proportion of consumers to obtain these effects. For example, when it is foreseeable to a reasonable manufacturer that a product will produce drug effects in consumers and be purchased by a substantial proportion of consumers for drug purposes, FDA may consider the product a "drug."

In the case of cigarettes and smokeless tobacco, no reasonable manufacturer could fail to foresee that these products will have significant pharmacological effects on consumers and be widely used by consumers for pharmacological purposes. All major public health organizations in the United States and abroad with expertise in tobacco or drug addiction now recognize that the nicotine delivered by cigarettes and smokeless tobacco is addictive. The first major organization to do so was the American Psychiatric Association, which in 1980 defined the "tobacco dependence disorder" and the "tobacco withdrawal syndrome." Since 1980, nicotine in tobacco products has also been recognized as addictive by the U.S. Surgeon General (1986 and 1988), the American Psychological Association (1988), the Royal Society of Canada (1989), the World Health Organization (1992), the American Medical Association (1993), and the Medical Research Council in the United Kingdom (1994). Every expert medical organization that submitted comments to FDA on whether nicotine is addictive concluded that it is. The tobacco industry's public position that nicotine is not addictive is simply not credible in light of this overwhelming scientific consensus.

The scientific consensus that cigarettes and smokeless tobacco cause addiction to nicotine makes it foreseeable to a reasonable manufacturer that these products will affect the structure and function of the body. This scientific consensus also makes it foreseeable that cigarettes and smokeless tobacco will be used by a substantial proportion of consumers for a pharmacological purpose-namely, to satisfy their addiction.

It is also foreseeable that the nicotine in cigarettes and smokeless tobacco will cause, and be used for, other significant pharmacological effects. It is well established that the nicotine in cigarettes and smokeless tobacco has psychoactive or mood-altering effects in the brain. Under some circumstances, nicotine can have a sedative or tranquilizing effect on the brain; under other circumstances, nicotine can have a stimulating or arousal-inducing effect. In this regard, nicotine is similar to other addictive drugs such as opiates, which can have both stimulating and sedating effects. In addition, nicotine plays a role in weight regulation, with substantial evidence demonstrating that cigarette smoking leads to weight loss.

Because a reasonable manufacturer would foresee that cigarettes and smokeless tobacco will cause and be used for these well-established pharmacological effects in a substantial proportion of consumers, the Agency finds that these drug effects and drug uses are intended by the manufacturers.

B. Consumers Use Tobacco Products to Obtain the Pharmacological Effects of Nicotine and to Satisfy Their Addiction

A second basis for establishing that a product is intended to affect the structure or function of the body is evidence showing that consumers actually use the product for pharmacological purposes. In fact, courts have recognized that even in the absence of any other evidence of intent to affect the structure or function of the body, such an intent may be established by evidence showing that consumers use the product "predominantly" for pharmacological purposes. ASH, 655 F.2d at 239-240.

In the case of cigarettes and smokeless tobacco, the evidence establishes that consumers do use these products "predominantly" for pharmacological purposes. Major recent studies have concluded that 77% to 92% of smokers are addicted to nicotine in cigarettes. The U.S. Department of Health and Human Services estimates that 75% of young regular users of smokeless tobacco are addicted to nicotine in these products. The comments from the American Heart Association, the American Lung Association, and the American Cancer Society, whose member physicians provide health care for tobacco users in the United States, confirm that "the vast majority of people who use nicotine containing cigarettes and smokeless tobacco do so to satisfy their craving for the pharmacological effects of nicotine; that is, to satisfy their drug dependence or addiction."

In addition, a large proportion of consumers also use cigarettes and smokeless tobacco for other pharmacological purposes. A recent survey found that over 70% of young people 10 to 22 years old who are daily smokers reported that they use cigarettes for relaxation. The same survey found that over 50% of young people who are daily users of smokeless tobacco reported that they use smokeless tobacco for relaxation. Other surveys show that between one-third and one-half of young smokers report that weight control is a reason for their smoking.

This evidence that consumers actually use cigarettes and smokeless tobacco predominantly to obtain the pharmacological effects of nicotine leads FDA to find that cigarettes and smokeless tobacco are intended to affect the structure and function of the body.

C. The Statements, Research, and Actions of the Cigarette Manufacturers Show that the Manufacturers Intend to Affect the Structure and Function of the Body

A third basis for establishing that a manufacturer intends to affect the structure or function of the body is evidence from the statements, research, and actions of the manufacturer that reveals that the manufacturer knows that its product will, or designs its product to, affect the structure or function of the body. It is a canon of statutory construction that words used by Congress should ordinarily be interpreted in accordance with their plain meaning. The plain meaning of "intend" includes "to have in mind" or "to design" for a particular use. The American Heritage Dictionary, for instance, defines "intend" as: "1. To have in mind; plan. 2.a. To design for a specific purpose. b. To have in mind for a particular use." Consistent with the plain meaning of "intend," FDA may consider whether the statements, research, and actions of the manufacturer show that the manufacturer "has in mind" that its product will, or "designs" its product to, affect the structure or function of the body.

The administrative record contains three decades of documents and other evidence from the major cigarette manufacturers. This evidence, most of which has only recently become available, establishes that the manufacturers do "have in mind" that their products will have and be used for pharmacological effects. First, the evidence shows that the cigarette manufacturers know that nicotine is a pharmacologically active drug. In internal documents, for instance, researchers for Philip Morris Inc. call nicotine "a powerful pharmacological agent with multiple sites of action" and "a physiologically active . . . substance . . . [which] alters the state of the smoker by becoming a neurotransmitter and a stimulant"; a researcher for R.J. Reynolds Tobacco Co. (RJR) calls nicotine "a potent drug with a variety of physiological effects"; and researchers for Brown & Williamson Tobacco Corp. and its parent company, BAT Industries PLC (formerly the British-American Tobacco Co.) (BATCO), call nicotine "pharmacologically active in the brain" and "an extremely biologically active compound capable of eliciting a range of pharmacological, biochemical, and physiological responses."

Second, the evidence establishes that the cigarette manufacturers have conducted extensive research to understand precisely how nicotine affects the structure and function of the body. In one year alone, Philip Morris conducted 16 different studies on the effects of nicotine, including 5 experiments to determine the pharmacological effects of nicotine on the human brain. RJR's similarly extensive research found that the nicotine in cigarettes produces measurable changes in brain wave activity, such as "a significant increase in beta2 magnitude" (an effect associated with anxiety relief) and "a significant decrease in delta magnitude" (an effect associated with improved mental condition). Through the Council for Tobacco Research, an organization formed by the major tobacco companies, the manufacturers funded dozens of sophisticated investigations concerning nicotine, including numerous studies that demonstrate nicotine's ability to alter the function of the human brain.

Third, the evidence shows that the manufacturers know that one of the pharmacological effects of nicotine is to cause and sustain addiction. Researchers and senior officials of Brown & Williamson and BATCO expressly acknowledge this fact in their internal documents, stating that "smoking is a habit of addiction" and that "nicotine is addictive." Philip Morris scientists also know of nicotine's addiction potential. They conducted a series of nicotine "self-administration" experiments using the tests used by the National Institute on Drug Abuse to determine whether a substance has addiction potential. These studies found that rats would self-administer nicotine, which is one of the hallmark characteristics of an addictive drug. Moreover, through the Council for Tobacco Research, the cigarette manufacturers funded research that reported that "smoking is a form of dependence no less binding than that of other addictive drugs."

Fourth, the evidence shows that the manufacturers know that consumers smoke cigarettes primarily to obtain the pharmacological effects of nicotine. This point is repeatedly acknowledged in internal company documents. For example, researchers for Philip Morris have stated that nicotine is "the primary reason why people smoke" and that nicotine is "the physiologically active component of smoke having the greatest consequence to the consumer"; researchers for RJR have stated that "the confirmed user of tobacco is primarily seeking the physiological 'satisfaction' derived from nicotine" and that "[w]ithout any question, the desire to smoke is based upon the effect of nicotine on the body"; and BATCO's director of research has stated that "[t]he tobacco smoking habit is reinforced or dependent upon the psycho-pharmacological effects mainly of nicotine." This knowledge of the central role of nicotine in cigarette smoking was communicated to the highest levels of the companies. In 1969, for instance, Philip Morris' vice president for research and development told the Philip Morris board of directors that "the ultimate explanation for the perpetuated cigarette habit resides in the pharmacological effect of smoke upon the body of the smoker."

Fifth, the evidence shows that in their internal documents, the cigarette manufacturers expressly refer to cigarettes as devices for the delivery of nicotine. For instance, researchers for Philip Morris have described cigarettes as a "dispenser for a dose unit of nicotine" and as a "nicotine delivery device"; a senior researcher for RJR has described cigarettes as a "vehicle for delivering nicotine"; and researchers for BATCO have described cigarettes as the "means of providing nicotine dose in a metered fashion" and as a device that provides the smoker "very flexible control over titrating his desired dose of nicotine."

This evidence establishes that cigarettes are intended by the manufacturers to affect the structure and function of the body. It demonstrates that the manufacturers know that nicotine is pharmacologically active; that consumers smoke primarily to obtain the pharmacological effects of nicotine; and that cigarettes function as devices for the delivery of nicotine. The evidence thus shows that when the manufacturers offer cigarettes for sale, they "have in mind" that their products will be used for the particular purpose of affecting the structure and function of the body.

In addition to the evidence showing that cigarette manufacturers "have in mind" the use of cigarettes for pharmacological purposes, the record shows that the manufacturers "design" cigarettes to ensure the delivery of a pharmacologically active dose of nicotine to the smoker. The evidence in the record shows that the manufacturers have conducted extensive product research and development to find ways to maintain adequate nicotine levels in low-tar cigarettes. According to one former senior official at Philip Morris, "a key objective of the cigarette industry over the last 20-30 years" was "maintaining an acceptable and pharmacologically active nicotine level" in low-tar cigarettes. Internal industry documents in the record disclose research to determine the dose of nicotine that must be delivered to provide "pharmacological satisfaction" to the smoker, as well as estimates by industry scientists of the minimum and optimum doses of nicotine that cigarettes must deliver.

Among the many examples in the record of product research and development to enhance relative nicotine deliveries, Philip Morris conducted extensive research to identify "the optimal nicotine/tar ratios for cigarette acceptability of relatively low-delivery cigarettes"; RJR developed alternative tobacco products that provide a "more efficient and direct way to provide the desired nicotine dosage than the present system involving combustion of tobacco"; and Brown & Williamson investigated chemical manipulation to raise smoke pH, thereby increasing "free" nicotine delivery, and used genetic engineering to breed a high-nicotine tobacco plant called Y-1.

The record before the Agency shows that several methods of enhancing nicotine deliveries are used in the manufacture of commercial cigarettes. Tobacco blending to raise the nicotine concentration in low-tar cigarettes is common. As the vice chairman and chief operating officer of Lorillard Tobacco Co. has stated, "the lowest tar segment is composed of cigarettes utilizing a tobacco blend which is significantly higher in nicotine." Another common technique for enhancing nicotine deliveries in low-tar cigarettes is the use of filter and ventilation systems that by design remove a higher percentage of tar than nicotine. Yet a third type of nicotine manipulation is the addition of ammonia compounds that increase the delivery of "free" nicotine to smokers by raising the alkalinity or pH of tobacco smoke. These ammonia technologies are widely used within the industry.

The record establishes that an important reason why the manufacturers design cigarettes that provide pharmacologically active doses of nicotine is to satisfy the demands of users. The manufacturers concede in their comments that their "intent is to design, manufacture and market . . . cigarettes to meet the preferences of adult smokers." The preferences of most smokers, however, include obtaining sufficient nicotine to sustain their addiction and to experience nicotine's mood-altering effects. What the cigarette manufacturers describe as producing cigarettes that satisfy consumer preferences is, in reality, producing cigarettes that provide the pharmacological effects of nicotine sought by consumers. The effect of maintaining a pharmacologically active dose of nicotine in cigarettes is to keep consumers smoking by sustaining their addiction.

The evidence that the manufacturers "design" cigarettes to provide a pharmacologically active dose of nicotine is further proof that the manufacturers intend cigarettes to affect the structure and function of the body. Taken together, the evidence shows that the cigarette manufacturers: (1) "have in mind" the use of cigarettes for the particular purpose of delivering the pharmacological effects of nicotine, and (2) "design" their products to provide these effects. This evidence convincingly demonstrates that the pharmacological effects of cigarettes are "intended" by the manufacturers.

D. The Statements, Research, and Actions of the Smokeless Tobacco Manufacturers Show that the Manufacturers Intend their Products to Affect the Structure and Function of the Body

The administrative record also contains evidence of the statements, research, and actions of the smokeless tobacco manufacturers. Like the evidence of the statements, research, and actions of the cigarette manufacturers, this evidence establishes that the smokeless tobacco manufacturers intend to affect the structure and function of the body.

First, the evidence in the record shows that the smokeless tobacco manufacturers know that nicotine is a pharmacologically active drug and that consumers use smokeless tobacco to obtain the pharmacological effects of nicotine. As a senior vice president for United States Tobacco Co. (UST) stated, "virtually all tobacco usage is based upon nicotine, 'the kick,' satisfaction." Researchers affiliated with Brown & Williamson acknowledge that "nicotine . . . absorbed through . . . the lining of the nose or mouth . . . will quickly enter a direct route, in the blood, to the brain."

Second, the evidence shows that the smokeless tobacco manufacturers manipulate the nicotine delivery of their products in a manner that promotes tolerance and addiction to nicotine. This manipulation is accomplished through the use of chemicals that alter the pH of the smokeless tobacco. Moist snuff brands that are marketed as "starter" brands have a low pH and consequently deliver a low level of "free" nicotine to the user, limiting the absorption of nicotine in the mouth. The low nicotine deliveries allow the new user to develop a tolerance to nicotine without experiencing adverse reactions such as nausea and vomiting. In contrast, moist snuff brands that are marketed to experienced users have a high pH and consequently deliver a high level of "free" nicotine to the user, increasing the amount of nicotine available for absorption. The increased nicotine deliveries provide sufficient nicotine to sustain the user's addiction.

Third, the evidence shows that smokeless tobacco use and addiction to nicotine has substantially increased among teenagers since the manufacturers began to manipulate nicotine deliveries. Before the introduction of starter brands with low levels of nicotine delivery, virtually no teenagers and young adults used smokeless tobacco. After the smokeless tobacco manufacturers began to market low-nicotine "starter" brands in the 1970's, however, use of smokeless tobacco by teenagers rose dramatically. Use of smokeless tobacco by adolescent males aged 18 to 19, for instance, increased almost 1,500% between 1971 and 1991. Most of the regular teenage users of smokeless tobacco graduate to higher nicotine brands. An analysis by the Centers for Disease Control and Prevention found that the pattern of smokeless tobacco use by teenagers "support[s] the hypothesis that snuff users in earlier stages of tobacco use and nicotine addiction use brands with low levels of free nicotine and then 'graduate' to brands with high levels."

This evidence of: (1) knowledge of nicotine pharmacology, (2) manipulation of nicotine deliveries, and (3) graduation to higher nicotine brands among young users is a sufficient basis to establish that the smokeless tobacco manufacturers intend to affect the structure and function of the body.

In addition to this industry-wide evidence of intended use, the record contains numerous documents from the nation's largest smokeless tobacco manufacturer, UST. The UST documents in the record show that:

These UST documents confirm that smokeless tobacco manufacturers deliberately produce brands with a range of nicotine deliveries in order to allow users to progress (or "graduate") from low-delivery products to high-delivery products. They thus corroborate the Agency's finding that smokeless tobacco is intended to affect the structure and function of the body.

E. The "Intended Use" of a Product Is Not Determined Only on the Basis of Promotional Claims

The principal legal argument of the tobacco industry is that the intended use of a product must be determined exclusively on the basis of the promotional claims made by the manufacturer. Under the industry's legal theory, the Agency must disregard the voluminous internal tobacco industry documents showing that the manufacturers have in mind, and design their products to provide, the pharmacological effects of nicotine. The tobacco industry also urges the Agency to disregard the evidence of the foreseeable pharmacological effects and uses of cigarettes and smokeless tobacco, as well as the evidence of the actual consumer use of these products for pharmacological purposes.

The Agency rejects the industry's legal argument. First, the industry's position is contrary to the plain language of the Act. The Act does not say that only products "promoted" to affect the structure or function of the body are drugs or devices. Rather, the Act says that products "intended" to affect the structure or function of the body are drugs or devices. The plain meaning of "intend" is significantly broader than the meaning of "promote." As summarized above, the plain meaning of "intend" includes "to have in mind" and "to design" for a particular use. The evidence that is relevant to determining the uses that a manufacturer "has in mind" or "designs" includes not just the promotional claims of the manufacturer, but also the internal statements of the manufacturer, as well as the manufacturer's research and actions. Moreover, the ordinary meaning of "intend" also encompasses the reasonably foreseeable consequences of the manufacturer's actions, thereby making consideration of the foreseeable pharmacological effects and uses of a product relevant to its intended use.

Second, the industry's position is contrary to FDA's regulations. These regulations provide that the term "intended use" refers to the "objective intent" of the manufacturer. Under these regulations, the Agency determines the intent of the manufacturer objectively by evaluating all of the relevant evidence in the record from the perspective of a reasonable fact-finder. FDA's regulations expressly direct the Agency to consider the manufacturer's "knowledge" of the use of the product; the manufacturer's "expressions" and "oral or written statements"; and the "circumstances surrounding the distribution of the article." 21 CFR 201.128, 801.4. Thus, the regulations expressly provide that the Agency should consider a broad range of evidence in determining intended use, not merely the manufacturer's promotional claims.

Third, the industry's position is contrary to judicial decisions interpreting the Act. These decisions have applied the Act's definitions of drug and device to two different types of products. The first type of product is one that contains no known drug ingredients and has no known pharmacological effects or uses. In cases involving such products, the courts recognize that a manufacturer's promotional claims have a crucial role in establishing intended use. Even a product like mineral water can be brought within FDA's jurisdiction by advertisements that make pharmacological claims. See Bradley v. United States, 264 F. 79 (5th Cir. 1920).

The situation is fundamentally different, however, when the product contains a known drug ingredient like nicotine that has known pharmacological effects and uses. When a product is pharmacologically active, the courts have recognized that "a fact finder should be free to pierce . . . a manufacturer's misleading . . . labels to find actual therapeutic intent on the basis of objective evidence." National Nutritional Foods Ass'n v. FDA, 504 F.2d 761, 789 (2d Cir. 1974). Thus, contrary to the industry's contention, the courts have recognized that in determining intended use, FDA may consider a wide range of evidence beyond the manufacturer's promotional claims, including evidence of the pharmacological effects of the product, e.g., United States v. Undetermined Quantities . . . "Pets Smellfree," 22 F.3d 235, 240 (10th Cir. 1994); the purposes for which consumers actually use the product, e.g., ASH, 655 F.2d at 239-240; the medical use of the product, e.g., United States v. An Article of Device . . . Toftness Radiation Detector, 731 F.2d 1253, 1257 (7th Cir. 1984); and how the product was formulated, e.g., American Health Products Co. v. Hayes, 574 F. Supp. 1498, 1508 (S.D.N.Y. 1983).

Fourth, the industry's position is contrary to FDA's administrative precedent. In a broad range of instances, FDA has asserted jurisdiction over products based on the likely pharmacological effects and uses of the product-not express promotional claims. Indeed, in many of these instances, the manufacturer's promotional claims were designed to disguise the actual intended use of the product.

Fifth, the industry's position is contrary to the public health objectives of the Act. If promotional claims alone determined the intended use of a product, virtually any manufacturer of drugs or devices could avoid the Act's reach by simply refraining from making pharmacological claims for the product. For instance, under the industry's interpretation, a company could market a potent tranquilizer or amphetamine for its "pleasurable" effect and escape FDA regulation. To protect the public from the unregulated distribution of products with pharmacologically active ingredients, the Agency must be able to look beyond a manufacturer's promotional claims when determining whether to regulate such products.

For these reasons, the Agency rejects the tobacco industry's legal theory that intended use is determined exclusively on the basis of promotional claims. The Agency also rejects the premise of the industry's position-namely, that their promotional claims demonstrate that cigarettes and smokeless tobacco are not intended to affect the structure and function of the body. To the contrary, as internal tobacco company documents indicate, promises of "satisfaction" in tobacco advertisements imply that cigarettes and smokeless tobacco will provide consumers with desired pharmacological effects of nicotine. These implied drug claims lend support to the Agency's finding that cigarettes and smokeless tobacco are intended to affect the structure and function of the body.

F. Response to Additional Comments

This section responds to additional comments regarding the evidence of the intended use of cigarettes and smokeless tobacco and the Agency's use of this evidence.

G. Considered Cumulatively, the Evidence Overwhelmingly Demonstrates that Cigarettes and Smokeless Tobacco Are Intended to Affect the Structure and Function of the Body

As summarized above, the evidence in the record provides several independent bases for the Agency's finding that cigarettes and smokeless tobacco are "intended" to affect the structure and function of the body. Independently, each of these distinct categories of evidence is a strong and sufficient basis for the Agency's conclusion that the manufacturers of cigarettes and smokeless tobacco intend the pharmacological effects and uses of their products. Considered together, they are mutually corroborating. Both independently and taken as a whole, therefore, the evidence in the administrative record overwhelmingly establishes that cigarettes and smokeless tobacco are "intended to affect the structure or any function of the body" within the meaning of the Act.

III. Cigarettes and Smokeless Tobacco Are Combination Products Consisting of "Drug" and "Device" Components

The Agency's findings in sections I and II establish that the nicotine in cigarettes and smokeless tobacco is a "drug" under section 201(g)(1)(C) of the Act. These findings show that the nicotine in cigarettes and smokeless tobacco "affect[s] the structure or any function of the body" and that these effects are "intended." These findings thus demonstrate that the nicotine in cigarettes and smokeless tobacco meets the statutory definition of a "drug."

Cigarettes and smokeless tobacco are not simply packaged nicotine, however. They also include delivery devices that deliver nicotine to the body. Section 201(h)(3), 21 U.S.C. 321(h)(3). In the case of cigarettes, the device components work together upon combustion outside the body to form a nicotine-containing aerosol, which then delivers nicotine to the body when inhaled by the smoker. In the case of smokeless tobacco, the device components function by presenting nicotine to the consumer in a form that is palatable and absorbable by the buccal mucosa. Unlike the drug nicotine, these device components achieve their primary intended purpose without chemical action in or on the body and without being metabolized.

The presence of both drug and device components in cigarettes and smokeless tobacco make these products "combination products" under section 503(g) the Act, 21 U.S.C. 353(g)(1).

IV. FDA's Assertion of Jurisdiction Over Cigarettes and Smokeless Tobacco at This Time Is Justified

FDA has always exercised jurisdiction over tobacco products when there is sufficient evidence in the record to establish that these products are "intended" to treat or prevent disease or to affect the structure or function of the body. Over thirty years ago, for instance, the Agency asserted jurisdiction over a brand of cigarettes when the evidence established that the brand was intended to reduce body weight. United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes, 178 F. Supp. 847 (D.N.J. 1959).

The Agency last considered whether to regulate cigarettes in the late 1970's, when the Agency rejected petitions by Action on Smoking and Health (ASH) urging the Agency to regulate cigarettes as drugs or devices. The Agency agreed with ASH that "objective evidence other than manufacturers' claims can be material to a determination of intended use" and that "evidence of consumer use can be one element of objective evidence to be weighed in determining if the intended purpose of a product subjects it to regulation under the Act." However, the Agency concluded that the evidence presented by ASH in the petition was insufficient to establish that cigarettes and smokeless tobacco were in fact intended to affect the structure and function of the body. The court deferred to the Agency's determination not to regulate cigarettes as drugs but expressly left open the possibility that FDA might, at a later date, revisit its decision and determine that it did indeed have jurisdiction over cigarettes. ASH v. Harris, 655 F.2d 236 (D.C. Cir. 1980).

The evidence regarding the intended use of cigarettes and smokeless tobacco has changed dramatically since ASH. First, a scientific consensus has emerged since 1980 that nicotine is addictive and has other significant pharmacological effects and that cigarettes and smokeless tobacco are used by consumers to obtain pharmacological effects. As summarized above, no major public health organization had determined that nicotine was an addictive drug before 1980. Between 1980 and 1994, however, every leading scientific organization with expertise in addiction concluded that nicotine is addictive. This new evidence thus shows that the pharmacological effects and uses of cigarettes and smokeless tobacco have become foreseeable.

Second, scientific evidence accumulated since 1980 has shown that the vast majority of people who use cigarettes and smokeless tobacco use these products to satisfy addiction or to obtain other pharmacological effects. As summarized above, this new evidence now shows that 77% to 92% of smokers are addicted to nicotine and provides a basis for estimating that 75% of young regular smokeless tobacco users are addicted to nicotine. This new evidence establishes that consumers use cigarettes and smokeless tobacco predominantly for pharmacological purposes.

Third, FDA, congressional, and other investigations have recently uncovered a wealth of documents from a wide range of tobacco companies that show that the manufacturers have long known of the pharmacological effects and uses of nicotine and have designed their products to provide pharmacologically active doses of nicotine to consumers. Virtually none of this information was available to FDA in 1980.

Information developed since 1980 also demonstrates that the Agency has a unique public health opportunity to reduce substantially the more than 400,000 deaths from tobacco use each year in the United States. This information shows that for most people tobacco use and nicotine addiction begin in childhood and adolescence, and that an increasing number of American children and adolescents are using cigarettes and smokeless tobacco. The data now suggest that if children and adolescents can be prevented from initiating tobacco use during their teenage years, they are unlikely to begin tobacco use later in life, thereby preventing the onset of tobacco-related disease and premature death.

Before the importance of youth-centered interventions was identified, most of the regulatory approaches available under the Federal Food, Drug, and Cosmetic Act to address tobacco-related disease and death, such as removal of the products from the market, were not believed to be feasible solutions. It is now apparent, however, that FDA's authority to restrict the sale, distribution, and use of cigarettes and smokeless tobacco to people under the age of eighteen is an effective tool to reduce the adverse health consequences of tobacco use. Thus, asserting jurisdiction over cigarettes and smokeless tobacco now presents an opportunity to use the Agency's resources effectively for substantial public health gains.

The court in ASH specifically recognized that FDA was permitted to modify its position and that any new FDA position would be accorded deference by the courts. Id. at 242 n.10. In light of the substantial new information, FDA has reviewed its earlier determination not to assert jurisdiction over tobacco products. The new evidence persuades the Agency to conclude that its previous position is no longer consistent with the relevant facts and should be changed. The evidence before the Agency is now sufficient to establish that cigarettes and smokeless tobacco are in fact intended to affect the structure and function of the body.

V. Congress Has Not Precluded or Preempted FDA from Regulating Cigarettes and Smokeless Tobacco

FDA disagrees with the comments of the tobacco industry that assert that Congress has precluded or preempted FDA from regulating cigarettes and smokeless tobacco. The plain language of the Act does not exclude cigarettes or smokeless tobacco from FDA jurisdiction. Tobacco products are expressly excluded from the jurisdiction of the Consumer Product Safety Commission under the Federal Hazardous Substances Act and from the jurisdiction of the Environmental Protection Agency under the Toxic Substances Control Act. The absence of any similar exclusion in the Federal Food, Drug, and Cosmetic Act demonstrates that Congress has not chosen to exclude cigarettes and smokeless tobacco from FDA jurisdiction.

The legislative history of the Act confirms that the Act should not be interpreted to preclude FDA jurisdiction over tobacco products. Congress has long known that FDA will assert jurisdiction over cigarettes when the evidence establishes that the cigarettes are intended to affect the structure or function of the body. For instance, FDA asserted jurisdiction more than 30 years ago over cigarettes that were intended to reduce weight. This demonstrates that Congress has not "ratified" or "acquiesced in" an interpretation of the Act that would preclude FDA from regulating tobacco products intended to affect the structure or function of the body.

Moreover, even if Congress had acquiesced in such an interpretation of the Act, congressional acquiescence in a prior agency interpretation does not prevent an agency from changing its interpretation. Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 45 (1983). In the case of cigarettes and smokeless tobacco, a change in interpretation would be justified by the new evidence in the record-evidence never previously before either the Agency or Congress.

The Agency also disagrees that other federal statutes preempt FDA jurisdiction over cigarettes and smokeless tobacco. Both the Federal Cigarette Labeling and Advertising Act and the Comprehensive Smokeless Tobacco Health Education Act have provisions that expressly specify the limited extent to which these laws preempt FDA and other federal agencies from regulating cigarettes or smokeless tobacco. In the Federal Cigarette Labeling and Advertising Act, for instance, federal agencies are preempted only from requiring "statement[s] relating to smoking and health . . . on any cigarette package." 15 U.S.C. 1334(a). The narrow preemption provisions that Congress expressly included in these statutes do not apply to FDA's assertion of jurisdiction over cigarettes and smokeless tobacco.

No other federal statutes contain provisions preempting FDA regulation of tobacco products. In the absence of an express preemption provision, one federal statute preempts another federal statute only where there is an irreconcilable conflict between the two laws. Connecticut Nat'l Bank v. Germain, 503 U.S. 249, 253 (1992). There is no irreconcilable conflict between FDA jurisdiction and other federal statutes.

VI. FDA Employed Procedures That Provided an Opportunity for Full Public Participation and Exceeded All Legal Requirements

FDA went to great lengths to involve the public in the process by which the Agency made its final jurisdictional determination. The Commissioner made public his intention to investigate the role of nicotine in tobacco products, testified twice before Congress on the Agency's findings, wrote to all the major cigarette and tobacco companies requesting information on the role of nicotine in their products, and held a public advisory committee meeting on the abuse potential of nicotine. Although the Agency is not required to undertake rulemaking to establish jurisdiction over new products, the Agency published in the Federal Register its initial jurisdictional findings and comprehensive legal analysis in a 325-page document, supported by over 600 footnotes, and sought public comment on those findings. The Agency placed over 210,000 pages of supporting documents in a public docket. FDA received over 700,000 comments on the Jurisdictional Analysis and the accompanying proposed rule. The Agency has responded to substantive comments in this Annex and in the preamble to the Final Rule.

FDA disagrees with the comments of the tobacco industry that the record supporting the Jurisdictional Analysis or the procedures the Agency followed were inadequate. The procedures the Agency employed in reaching its final determination exceeded the requirements of the Administrative Procedures Act (APA) and the Agency's own procedural requirements.

Last revised August 1996.

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